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Trial record 49 of 1948 for:    Sexually Transmitted Diseases | NIH

HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183573
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 7, 2013
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Rochester
Syracuse University
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE March 2004
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Sexual behavior [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Sexual behavior
Change History Complete list of historical versions of study NCT00183573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
STD incidence [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
STD incidence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
Official Title  ICMJE HIV Prevention for STD Clinic Patients
Brief Summary This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).
Detailed Description

Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.

At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.

Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Sexually Transmitted Diseases
Intervention  ICMJE
  • Behavioral: Brief Motivational Intervention
    15-20 minute, motivational one-on-one counseling
  • Behavioral: Brief Informational Intervention
    15 minute informational DVD on safer sex
  • Behavioral: Intensive Informational Intervention
    4-hour, information-only intensive group workshop
  • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
    4-hour, intensive group workshop with emphasis on motivation and skills
Study Arms  ICMJE
  • Experimental: 1
    Brief Motivational Intervention only
    Intervention: Behavioral: Brief Motivational Intervention
  • Experimental: 2
    Brief Informational Intervention only
    Intervention: Behavioral: Brief Informational Intervention
  • Experimental: 3
    Brief Motivational Intervention + Intensive Informational Intervention
    Interventions:
    • Behavioral: Brief Motivational Intervention
    • Behavioral: Intensive Informational Intervention
  • Experimental: 4
    Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
    Interventions:
    • Behavioral: Brief Motivational Intervention
    • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
  • Experimental: 5
    Brief Informational Intervention + Intensive Informational Intervention
    Interventions:
    • Behavioral: Brief Informational Intervention
    • Behavioral: Intensive Informational Intervention
  • Experimental: 6
    Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
    Interventions:
    • Behavioral: Brief Informational Intervention
    • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
1554
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
  • Able to understand English

Exclusion Criteria:

  • Psychosis or impaired mental status that would prevent participant from providing informed consent
  • Have been tested for HIV within 3 months prior to study entry
  • HIV infected
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00183573
Other Study ID Numbers  ICMJE R01MH068171( U.S. NIH Grant/Contract )
R01MH068171 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael P. Carey, The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of Rochester
  • Syracuse University
Investigators  ICMJE
Principal Investigator: Michael P. Carey, PhD Syracuse University
PRS Account The Miriam Hospital
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP